- ≥1 year durable transfusion independence (1-year TI) achieved in 29% of IMerge Phase 2 patients, with a median TI duration of 1.8 years
- In patients previously treated with luspatercept, 33% achieved 1-year TI
- Strong evidence of disease modification in patients with 1-year TI as indicated by ≥3g/dL increases in hemoglobin, as well as reductions in SF3B1 variant allele frequency (VAF) that were correlated with longer TI duration and shorter time to onset of TI
- Top-line results from ongoing IMerge Phase 3 clinical trial expected in early January 2023
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced results from an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting on longer follow-up data from the IMerge Phase 2 clinical trial of imetelstat, the Company’s first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). The data in the presentation focused on the patients who achieved greater than one-year sustained continuous transfusion independence and included their baseline characteristics, clinical benefits and observed safety profile.
“Achievement of one year or more uninterrupted transfusion independence represents significant clinical benefit given the high transfusion burden of the patients in the IMerge Phase 2 trial,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “The durability of transfusion independence, which was correlated to decreases in mutated cells with variant alleles, provide strong evidence of disease modification with imetelstat treatment. If the data from the Phase 2 are confirmed by the top-line results from IMerge Phase 3, which we expect in early January 2023, imetelstat could transform the lower risk MDS treatment landscape.”
Longer Follow-Up Data from IMerge Phase 2 Clinical Trial in Lower Risk MDS
IMerge Phase 2 is an open label, single arm study to assess the efficacy and safety of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (lower risk MDS), who are relapsed or refractory to prior treatment with erythropoiesis stimulating agents (ESAs). The primary efficacy endpoint is 8-week transfusion independence (TI) rate, which is defined as the proportion of patients achieving red blood cell TI during any consecutive eight weeks since entry into the trial. Secondary endpoints include 24-week TI rate and duration of TI.
The oral presentation at ASH described the 29% (11/38) of patients in IMerge Phase 2 who achieved ≥1 year sustained continuous TI with imetelstat. The median time on study for these patients was approximately 4.8 years with a median treatment duration of approximately 2.4 years. For these 11 patients, the median TI duration was approximately 1.8 years, which is the longest reported to date with imetelstat. In addition, these patients experienced increases in hemoglobin ≥3g/dL. Furthermore, these 11 patients represented 69% of the ≥8-week TI responders and 92% of the ≥24-week TI responders. As such, attainment of 24-week TI was indicative of the likelihood to achieve TI ≥1 year.
New efficacy data related to the 16% (6/38) of patients in IMerge Phase 2 who were relapsed/refractory to ESAs and had also been treated previously with luspatercept are as follows:
- 50% (3/6) of these patients achieved ≥8-week TI
- 67% (2/3) of those ≥8-week TI responders also achieved ≥24-week TI
- 100% (2/2) of those ≥24-week TI responders also achieved >1 year TI
Safety findings for the 11 patients were consistent with the overall patients in the target population, including resolution of each of Grade 3/4 thrombocytopenia and neutropenia to Grade 2 or lower within 4 weeks for >97% of patients in the >1 year TI population.
Mutation data were available for nine of the 11 patients, and 89% had a reduction in SF3B1 variant allele frequency (VAF) while 56% achieved greater than or equal to 50% VAF reduction. Reduction in VAF correlated with longer TI duration (median, >20 months) and shorter time to onset of TI (median,